- Late-Breaking Full Results from HIV
Prevention Research of Twice-Yearly Injectable Lenacapavir
-
- Progress and Person-Centered Approaches
Across HIV Treatment, Cure Research and Development Programs
-
- Key Initiatives Demonstrate Commitment to
Collaboration to Help End the HIV Epidemic Worldwide -
Gilead Sciences, Inc. (Nasdaq: GILD) today announced its program
for the upcoming 25th International AIDS Conference (AIDS 2024),
taking place in Munich, Germany, and virtually, from July 22-26. As
the leading innovator in HIV, Gilead will share new data from its
research and development programs and Gilead-supported
collaborations that unite leading scientific innovation and
partnership aimed at ending the HIV epidemic.
"The AIDS 2024 conference convenes the global HIV community –
scientists, advocates, and partners from the public and private
sectors," said Jared Baeten, MD, PhD, Senior Vice President,
Virology Clinical Development, Gilead Sciences. "Our contributions
to this year's meeting demonstrate Gilead's leadership in
person-centered innovations across HIV prevention, treatment, and
cure. Our scientific advancements are grounded in collaboration
with community and research partners around the world. I look to a
future where every person has options to help obtain their own HIV
prevention or treatment success and where we've come together to
end the HIV epidemic."
Gilead’s AIDS 2024 program highlights include:
Late-breaking: Full data from pivotal PURPOSE 1 trial:
Data evaluating lenacapavir, an investigational, twice-yearly
medicine for HIV prevention, will be presented at the Co-Chairs’
Choice session on July 24, 10:30 a.m.-noon, CEST. Developed in
partnership with communities affected by HIV around the world, the
PURPOSE clinical trials comprise the most comprehensive and diverse
HIV prevention trial program ever conducted. PURPOSE 1 is the first
HIV prevention trial to intentionally include pregnant and
lactating women. In June, the topline results from an interim
analysis of the Phase 1 trial were announced, demonstrating 100%
efficacy for the investigational use of HIV prevention in cisgender
women.
Oral presentation: Week 48 outcomes from ARTISTRY-1: The
latest data from an ongoing Phase 2/3 study (NCT05502341) designed
to evaluate an investigational once-daily single-tablet regimen of
bictegravir and lenacapavir in virologically suppressed people with
HIV who are on a complex regimen.
Two-year outcomes from BICSTaR: The latest findings from
an ongoing global, observational study evaluating the
effectiveness, safety and tolerability of Biktarvy® (bictegravir 50
mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets,
B/F/TAF) in treatment-naïve and treatment-experienced people with
HIV who have a high burden of co-morbidities.
Additional research studies evaluating Biktarvy include
five-year outcomes from the pivotal trials evaluating Biktarvy as a
long-term treatment option in older adults with a high burden of
comorbidities and the Hispanic/Latine community, respectively.
HIV treatment research pipeline findings will also include new
data on GS-1720 and GS-4182. Both investigational agents are being
clinically evaluated as part of potential future once-weekly oral
HIV treatment options. Additionally, resistance analyses from a
study evaluating the investigational combination of lenacapavir +
teropavimab (GS-5423, TAB) + zinlirvimab (GS-2872, ZAB) will be
presented to support previously presented data demonstrating the
potential of this combination as a novel, long-acting, twice-yearly
treatment option.
Symposia focused on addressing barriers to HIV care and
prevention: Two symposia to discuss the latest progress in
policies and practical solutions from around the world to help
achieve more equitable access to HIV care and services.
- What’s Preventing Us From Preventing? Pushing Together Towards
the UNAIDS 2030 HIV Prevention Goals (July 24, 7-8 a.m., CEST) will
convene experts and community members to strategize about working
to achieve UNAIDS 2030 goals. Topics include forward-thinking
policies, person-centered care and innovative solutions for health
equity.
- How Treatment Selection Can Support Long-Term Success (July 25,
12-1 p.m., CEST) will bring together providers and the HIV
community to explore ways to help achieve long-term success in HIV
management. Discussions will focus on the importance of treatment
selection from the outset, aiming for long-term, durable viral
suppression.
Gilead-supported initiatives highlighting collaboration to
advance health equity: To help end the HIV epidemic, it is
essential to extend beyond science. Gilead will highlight two
initiatives that aim to bridge gaps in HIV awareness and improve
linkage to and retention in care:
- The Person-Centered Care (PCC) Program with the International
AIDS Society (IAS) is a multidisciplinary, integrated and
long-term, focused approach to care for people with and affected by
HIV that is responsive to their evolving needs, priorities and
preferences.
- RADIAN® – a groundbreaking partnership between Gilead and the
Elton John AIDS Foundation (EJAF) – will host a community exchange
event, led by community leaders from Eastern Europe and Central
Asia (EECA), to discuss how RADIAN-supported innovation and
services are elevating efforts to end the HIV crisis in EECA.
Overview of Scientific Presentations
HIV TREATMENT RESEARCH
(B/F/TAF)
Efficacy and Safety of B/F/TAF in
Hispanic/Latine Adults With HIV-1 Initiating First-Line Therapy:
5-Year Follow-Up From Two Phase 3 Studies
Switching To B/F/TAF in A Real-World
Cohort of Older People With HIV And High Burden of Non AIDS-Related
Comorbidities (BICSTaR)
LONG-ACTING HIV TREATMENT &
PREVENTION RESEARCH (LENACAPAVIR)
Centring Community Leadership With
Purpose: Inclusion Of Adolescents, Ciswomen, and Pregnant And
Lactating Individuals in a Phase 3 Clinical Trial Evaluating
Lenacapavir and F/TAF For PrEP
Twice-Yearly Lenacapavir or Daily
Emtricitabine/Tenofovir Alafenamide for HIV Prevention in Cisgender
Women: Interim Analysis Results from the PURPOSE 1 Study
Experiences and Quality of Life with
Long-Acting Lenacapavir from People With Multidrug-Resistant HIV-1
Enrolled in the Phase 2/3 CAPELLA Study
Injection Site Reactions with Subcutaneous
Lenacapavir Administration at Alternate Injection Sites
Resistance Analyses During Treatment of
Lenacapavir With Broadly Neutralizing Antibodies in PWH
HIV PIPELINE RESEARCH
Efficacy and Safety of Bictegravir Plus
Lenacapavir: 48-Week Outcomes in Virologically Suppressed People
With HIV-1 on Complex ART Regimens at Baseline (Artistry-1)
Phase 1a PK and Safety of Single Ascending
Doses of GS-1720 in Healthy Participants Supports Oral Weekly
Administration and Phase 1b Dose Selection
Nonclinical Pharmacology Profile of
GS-1720, a Novel, Highly Potent Once-Weekly Oral HIV-1 INSTI
Inhibitor in Clinical Development
Safety and PK Profile of Single and
Multiple Ascending Doses of GS-4182, an Oral Prodrug of
Lenacapavir, in Participants Without HIV-1
Nonclinical Profile of GS-4182, a
Once-Weekly Oral Prodrug of the HIV-1 Capsid Inhibitor Lenacapavir
in Clinical Development
ADDITIONAL HIV PREVENTION
RESEARCH
Real-World Adherence of HIV-1 Oral PrEP
Regimens in the United States: A Group-Based Trajectory Modeling
Approach
HIV CURE RESEARCH
GS-8588, a Novel Envelope-Targeting
Bispecific T-Cell Engager for HIV Cure
For more information, including a complete list of abstracts and
their corresponding oral and poster session titles, please visit:
https://programme.aids2024.org/
Bictegravir and lenacapavir in combination are investigational
and not approved anywhere globally. Their safety and efficacy have
not been established.
GS-5423, GS-2872, GS-1720, GS-4182 and GS-8588 are
investigational compounds, and alone or in combination with
lenacapavir, are not approved by the U.S. Food and Drug
Administration or any other regulatory authority for any use. Their
safety and efficacy are unknown.
Lenacapavir, marketed as Sunlenca®, is being studied in multiple
ongoing early and late-stage development programs and has the
potential to offer a diverse set of person-centric options for
treatment and prevention that could uniquely fit into the lives of
people with HIV and individuals who need or want pre-exposure
prophylaxis (PrEP).
The use of lenacapavir for HIV prevention is investigational and
the safety and efficacy of lenacapavir for this use have not been
established. Lenacapavir is being evaluated as a long-acting option
in multiple ongoing and planned early and late-stage clinical
studies in Gilead’s HIV prevention and treatment research
program.
Please see below for U.S. Indication and Important Safety
Information, including Boxed Warning, for Biktarvy. Please
also see below for the U.S. Indication and Important Safety
Information for Sunlenca.
There is currently no cure for HIV or AIDS.
About Biktarvy
Biktarvy is a complete HIV treatment that combines three
powerful medicines to form the smallest 3-drug, integrase strand
transfer inhibitor (INSTI)-based single-tablet regimen (STR)
available, offering simple once-daily dosing with or without food,
with a limited drug interaction potential and a high barrier to
resistance. Biktarvy combines the novel, unboosted INSTI
bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir
alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete
STR and should not be taken with other HIV medicines.
About Sunlenca
Sunlenca (300 mg tablet and 463.5 mg/1.5 mL injection)
[(lenacapavir)] is a first-in-class, long-acting HIV capsid
inhibitor approved in Australia, Canada, the European Union,
Israel, Japan, Switzerland, the United Arab Emirates, the United
Kingdom, and the United States for the treatment of HIV-1
infection, in combination with other antiretroviral(s), in adults
with multi-drug resistant HIV who are heavily
treatment-experienced. Sunlenca is the only HIV treatment option
administered twice-yearly. Sunlenca tablets are approved for oral
loading during initiation of Sunlenca treatment, prior to or at the
time of the first long-acting lenacapavir injection depending on
initiation option.
The multi-stage mechanism of action of Sunlenca’s active
pharmaceutical agent, lenacapavir, is distinguishable from other
currently approved classes of antiviral agents. While most
antivirals act on just one stage of viral replication, Sunlenca is
designed to inhibit HIV at multiple stages of its lifecycle and has
no known cross resistance exhibited in vitro to other existing drug
classes.
Lenacapavir is being evaluated as a long-acting option in
multiple ongoing and planned early and late-stage clinical studies
in Gilead's HIV prevention and treatment research program.
Lenacapavir for HIV prevention is investigational, and its safety
and efficacy for this use have not been established. Lenacapavir is
being developed as a foundation for potential future HIV therapies
with the goal of offering both long-acting oral and injectable
options with several dosing frequencies, in combination or as a
mono agent, that help address individual needs and preferences of
people and communities affected by HIV.
U.S. Indication for
Biktarvy
Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir
alafenamide 25 mg) is indicated as a complete regimen for the
treatment of HIV-1 infection in adults and pediatric patients
weighing at least 14 kg who have no antiretroviral (ARV) treatment
history or to replace the current ARV regimen in those who are
virologically-suppressed (HIV-1 RNA <50 copies per mL) on a
stable ARV regimen with no known or suspected substitutions
associated with resistance to bictegravir or tenofovir.
U.S. Important Safety Information for
Biktarvy
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS
B
- Severe acute exacerbations of hepatitis B have been reported in
patients who are coinfected with HIV-1 and HBV and have
discontinued products containing emtricitabine (FTC) and/or
tenofovir disoproxil fumarate (TDF), and may occur with
discontinuation of BIKTARVY. Closely monitor hepatic function with
both clinical and laboratory follow-up for at least several months
in patients who are coinfected with HIV-1 and HBV and discontinue
BIKTARVY. If appropriate, anti-hepatitis B therapy may be
warranted.
Contraindications
- Coadministration: Do not use BIKTARVY with dofetilide or
rifampin.
Warnings and precautions
- Drug interactions: See Contraindications and Drug
Interactions sections. Consider the potential for drug interactions
prior to and during BIKTARVY therapy and monitor for adverse
reactions.
- Immune reconstitution syndrome, including the occurrence
of autoimmune disorders with variable time to onset, has been
reported.
- New onset or worsening renal impairment: Postmarketing
cases of renal impairment, including acute renal failure, proximal
renal tubulopathy (PRT), and Fanconi syndrome have been reported
with tenofovir alafenamide (TAF)–containing products. Do not
initiate BIKTARVY in patients with estimated creatinine clearance
(CrCl) <30 mL/min except in virologically suppressed adults
<15 mL/min who are receiving chronic hemodialysis. Patients with
impaired renal function and/or taking nephrotoxic agents (including
NSAIDs) are at increased risk of renal-related adverse reactions.
Discontinue BIKTARVY in patients who develop clinically significant
decreases in renal function or evidence of Fanconi syndrome. Renal
monitoring: Prior to or when initiating BIKTARVY and during
therapy, assess serum creatinine, CrCl, urine glucose, and urine
protein in all patients as clinically appropriate. In patients with
chronic kidney disease, assess serum phosphorus.
- Lactic acidosis and severe hepatomegaly with steatosis:
Fatal cases have been reported with the use of nucleoside analogs,
including FTC and TDF. Discontinue BIKTARVY if clinical or
laboratory findings suggestive of lactic acidosis or pronounced
hepatotoxicity develop, including hepatomegaly and steatosis in the
absence of marked transaminase elevations.
Adverse reactions
- Most common adverse reactions (incidence ≥5%; all
grades) in clinical studies through week 144 were diarrhea (6%),
nausea (6%), and headache (5%).
Drug interactions
- Prescribing information: Consult the full prescribing
information for BIKTARVY for more information on Contraindications,
Warnings, and potentially significant drug interactions, including
clinical comments.
- Enzymes/transporters: Drugs that induce P-gp or induce
both CYP3A and UGT1A1 can substantially decrease the concentration
of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or
inhibit both CYP3A and UGT1A1 may significantly increase the
concentrations of components of BIKTARVY. BIKTARVY can increase the
concentration of drugs that are substrates of OCT2 or MATE1.
- Drugs affecting renal function: Coadministration of
BIKTARVY with drugs that reduce renal function or compete for
active tubular secretion may increase concentrations of FTC and
tenofovir and the risk of adverse reactions.
Dosage and administration
- Dosage: Adult and pediatric patients weighing ≥25 kg: 1
tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine
(FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with
or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1
tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once
daily with or without food. For children unable to swallow a whole
tablet, the tablet can be split and each part taken separately as
long as all parts are ingested within approximately 10
minutes.
- Renal impairment: For patients weighing ≥25 kg, not
recommended in patients with CrCl 15 to <30 mL/min, or <15
mL/min who are not receiving chronic hemodialysis, or <15 mL/min
who are receiving chronic hemodialysis and have no antiretroviral
treatment history. For patients weighing ≥14 kg to <25 kg, not
recommended in patients with CrCl <30 mL/min.
- Hepatic impairment: Not recommended in patients with
severe hepatic impairment.
- Prior to or when initiating: Test patients for HBV
infection.
- Prior to or when initiating, and during treatment: As
clinically appropriate, assess serum creatinine, CrCl, urine
glucose, and urine protein in all patients. In patients with
chronic kidney disease, assess serum phosphorus.
Pregnancy and lactation
- Pregnancy: BIKTARVY is recommended in pregnant
individuals who are virologically suppressed on a stable ARV
regimen with no known substitutions associated with resistance to
any of the individual components of BIKTARVY. Lower plasma
exposures of BIKTARVY were observed during pregnancy; therefore,
viral load should be monitored closely during pregnancy.
- Lactation: Individuals infected with HIV-1 should be
informed of the potential risks of breastfeeding.
U.S. Indication for
Sunlenca
Sunlenca, a human immunodeficiency virus type 1 (HIV-1) capsid
inhibitor, in combination with other antiretroviral(s), is
indicated for the treatment of HIV-1 infection in heavily
treatment-experienced adults with multidrug resistant HIV-1
infection failing their current antiretroviral regimen due to
resistance, intolerance, or safety considerations.
U.S. Important Safety Information for
Sunlenca
Contraindications
- Coadministration: Concomitant administration of Sunlenca
is contraindicated with strong CYP3A inducers.
Warnings and precautions
- Immune reconstitution syndrome, including the occurrence
of autoimmune disorders with variable time to onset, has been
reported in patients treated with combination antiretroviral (ARV)
therapy.
- Long-acting properties and potential associated risks with
Sunlenca: Residual concentrations of Sunlenca may remain in the
systemic circulation of patients for up to 12 months or longer.
Sunlenca may increase exposure, and potential risk of adverse
reactions, to drugs primarily metabolized by CYP3A initiated within
9 months after last injection. Counsel patients regarding the
dosing schedule because nonadherence could lead to loss of
virologic response and development of resistance. If virologic
failure occurs, switch to an alternative regimen if possible. If
discontinuing Sunlenca, begin alternate suppressive ARV regimen
within 28 weeks from last injection.
- Injection site reactions may occur, and nodules and
indurations may be persistent.
Adverse reactions
- Most common adverse reactions (incidence ≥3%, all
grades) are injection site reactions (65%) and nausea (4%).
Drug interactions
- Prescribing information: Consult the full prescribing
information for Sunlenca for more information on Contraindications,
Warnings, and potentially significant drug interactions, including
clinical comments.
- Enzymes/transporters: Drugs that are strong or moderate
inducers of CYP3A may significantly decrease the concentration of
Sunlenca. Drugs that strongly inhibit CYP3A, P-gp, and UGT1A1
together may significantly increase the concentration of Sunlenca.
Sunlenca may increase the exposure of drugs primarily metabolized
by CYP3A, when initiated within 9 months after the last injection
of Sunlenca, which may increase the potential risk of adverse
reactions.
Dosage and administration
- Dosage: Initiation with 1 of 2 options, followed by
maintenance dosing once every 6 months. Tablets may be taken with
or without food.
- Initiation Option 1: Day 1: 927 mg by subcutaneous
injection and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg
orally (2 x 300-mg tablets).
- Initiation Option 2: Day 1: 600 mg orally (2 x 300-mg
tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Day 8: 300 mg
orally (1 x 300-mg tablet). Day 15: 927 mg by subcutaneous
injection.
- Maintenance: 927 mg by subcutaneous injection every 26
weeks +/- 2 weeks from date of last injection.
- Missed Dose: During the maintenance period, if more than
28 weeks have elapsed since the last injection and if clinically
appropriate to continue Sunlenca treatment, restart the initiation
dosage regimen from Day 1, Option 1 or Option 2.
Pregnancy and lactation
- Pregnancy: There is insufficient human data on the use
of Sunlenca during pregnancy. An Antiretroviral Pregnancy Registry
(APR) has been established.
- Lactation: Individuals infected with HIV-1 should be
instructed not to breastfeed, due to the potential for HIV-1
transmission.
About Gilead Sciences in
HIV
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis, COVID-19, and cancer. Gilead operates in more than
35 countries worldwide, with headquarters in Foster City,
California.
For more than 35 years, Gilead has been a leading innovator in
the field of HIV, driving advances in treatment, prevention and
cure research. Gilead researchers have developed 12 HIV
medications, including the first single-tablet regimen to treat
HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP)
to help reduce new HIV infections, and the first long-acting
injectable HIV treatment medication administered twice-yearly. Our
advances in medical research have helped to transform HIV into a
treatable, preventable, chronic condition for millions of
people.
Gilead is committed to continued scientific innovation to
provide solutions for the evolving needs of people affected by HIV
around the world. Through partnerships, collaborations and
charitable giving, the company also aims to improve education,
expand access and address barriers to care, with the goal of ending
the HIV epidemic worldwide. Gilead is recognized as one of the
leading funders of HIV-related programs in a report released by
Funders Concerned About AIDS.
Learn more about Gilead’s unique collaborations worldwide and
the work to help end the global HIV epidemic.
Forward-Looking
Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including Gilead’s ability to initiate, progress or complete
clinical trials or studies within currently anticipated timelines
or at all, and the possibility of unfavorable results from ongoing
and additional clinical trials or studies, including those
involving Biktarvy, lenacapavir, teropavimab, zinlirvimab, GS-1720,
GS-4182 and GS-8588; uncertainties relating to regulatory
applications and related filing and approval timelines, including
potential applications for indications currently under evaluation;
the possibility that Gilead may make a strategic decision to
discontinue development of these programs and, as a result, these
programs may never be successfully commercialized for the
indications currently under evaluation; and any assumptions
underlying any of the foregoing. These and other risks,
uncertainties and factors are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2024,
as filed with the U.S. Securities and Exchange Commission. These
risks, uncertainties and other factors could cause actual results
to differ materially from those referred to in the forward-looking
statements. All statements other than statements of historical fact
are statements that could be deemed forward-looking statements. The
reader is cautioned that any such forward-looking statements are
not guarantees of future performance and involve risks and
uncertainties and is cautioned not to place undue reliance on these
forward-looking statements. All forward-looking statements are
based on information currently available to Gilead, and Gilead
assumes no obligation and disclaims any intent to update any such
forward-looking statements.
U.S. Prescribing Information for Biktarvy,
including BOXED WARNING, and U.S. full Prescribing
Information for Sunlenca are available at www.gilead.com
Biktarvy, Descovy, Sunlenca, RADIAN, Gilead and
the Gilead logo are registered trademarks of Gilead Sciences, Inc.,
or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on X
(@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs
at public_affairs@gilead.com, 1-800-GILEAD-5 or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20240716578075/en/
Jacquie Ross, Investors investor_relations@gilead.com
Ashleigh Koss, Media public_affairs@gilead.com
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